Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT00828594
Status:
TERMINATED
Last Update Posted:
2013-04-11
First Post:
2009-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-09', 'studyFirstSubmitDate': '2009-01-09', 'studyFirstSubmitQcDate': '2009-01-23', 'lastUpdatePostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose of combination RAD001+sorafenib', 'timeFrame': 'Until maximum tolerated dose is determined'}, {'measure': 'Time to disease progression assessed when 60 events have been observed', 'timeFrame': 'Until number of events are reached'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events', 'timeFrame': 'Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity'}, {'measure': 'Tumor response', 'timeFrame': 'Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity'}, {'measure': 'Biomarkers- effect of treatment on soluble markers of angiogenesis and apoptosis', 'timeFrame': 'Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity'}, {'measure': 'Overall tumor response (phase 2)', 'timeFrame': 'Estimate of 1 year for each patient - Until number of events reached and final analysis'}, {'measure': 'Progression Free Survivor, Overall Survivor (phase 2)', 'timeFrame': 'Estimate of 1 year for each patient - Until number of events reached and final analysis'}, {'measure': 'Safety and tolerability - of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events (phase 2)', 'timeFrame': 'Estimate of 1 year for each patient - Until number of events reached and final analysis'}, {'measure': 'Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose (phase 2)', 'timeFrame': 'Estimate of 1 year for each patient - Until number of events reached and final analysis'}, {'measure': 'Biomarkers effect of treatment on soluble markers of angiogenesis and apoptosis (phase 2)', 'timeFrame': 'Estimate of 1 year for each patient - Until number of events reached and final analysis'}, {'measure': 'Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose', 'timeFrame': 'Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity'}]}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'dose-finding study', 'randomized trial', 'medical treatment', 'RAD001', 'sorafenib', 'Advanced hepatocellular cancer (HCC)'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Phase 1 Evaluate the safety and tolerability of RAD001 in combination with sorafenib in patients with advance hepatocellular cancer (HCC) and to determine the maximum tolerated dose (MTD)\n\nPhase 2 To estimate the treatment effect as a measure of anti-tumor activity in terms of Time to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD, as compared to sorafenib alone'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced liver cancer\n* No previous systemic therapy for liver cancer\n* Measurable disease on CT or MRI\n* ECOG 1 or less\n* Child-Pugh A\n\nExclusion Criteria:\n\n* Active bleeding during the last 30 days\n* Known history of HIV seropositivity\n* Any severe and/or uncontrolled medical conditions including\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00828594', 'briefTitle': 'Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 1 Open Label/ Phase 2 Randomized, Double-blind, Multicenter Study Investigating the Combination of RAD001 and Sorafenib (Nexavar®) in Patients With Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'CRAD001O2101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1: RAD001 plus sorafenib', 'interventionNames': ['Drug: RAD001', 'Drug: RAD001, sorafenib']}], 'interventions': [{'name': 'RAD001', 'type': 'DRUG', 'armGroupLabels': ['Phase 1: RAD001 plus sorafenib']}, {'name': 'RAD001, sorafenib', 'type': 'DRUG', 'armGroupLabels': ['Phase 1: RAD001 plus sorafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90005', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Department of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Invstigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}